MAUDE Adverse Event Report: BECKMAN COULTER ACCESS GI MONITOR CANCER ANTIGEN 19-9; SYSTEM,TEST,CARBOHYDRATE ANTIGEN(CA19-9),FOR MONITOR,MANAGE OF PANCREATIC CANCER

Model Number	387687
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The full patient identifier is (b)(6).The access gi monitor reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.No other patient results were called into question.The customer reported heterophile antibody testing was performed and did not demonstrate the presence of heterophile antibody.Per the access gi monitor instructions for use a83874 m, it states "the access gi monitor results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information." in conclusion, there is sufficient evidence to suggest a discordance malfunction occurred as results obtained on the access gi monitor assay were discordant with the clinical presentation of the patient and a result obtained on an alternate device.An assignable cause of the discordance malfunction cannot be determined.There were no reports of error messages, quality control failures, issues with samples from other patients in connection with the event that would demonstrate an issue with the system.
Event or Problem Description
On (b)(6) 2023 the customer reported obtaining a false elevated access gi monitor (ca 19-9) (lot number 125586) result involving the laboratory's unicel dxi 800 access immuno analyzer (serial number (b)(4)).The access gi monitor result of 68.1 u/ml obtained on (b)(6) 2023 was discordant with the gi monitor result of 18 u/ml obtained on the siemens platform (reference range =37 u/ml).The expected values for the access gi monitor (ca 19.9) assay are <35 u/ml.The customer also reported that the access gi monitor result was discordant with the imaging test results as the patient¿s lesions were observed to be decreasing.The customer reported the patient was ordered imaging tests (type of imaging performed was not provided) because of the high access gi monitor result.No additional impact or change to patient treatment was reported in connection with the event.No hardware errors or issues with other assays were reported in conjunction with this event.No issues with system check were reported in connection with the event.Calibration data was not provided.Quality control (qc) was passing within the laboratory¿s established ranges.The customer reported heterophile antibody testing was performed and did not demonstrate the presence of heterophile antibody.There were no issues with sample integrity reported by the customer.No further sample information was provided.
Event or Problem Description
The customer reported the patient was ordered imaging tests because of the high access gi monitor result.On (b)(6)2023, the customer did indicate that the imaging tests were pet (positron emission tomography) scan (fdg 1 -f) and tomography without contrast that have demonstrated a decrease in lesion.No additional impact to the patient was reported in connection with the event.
Additional Manufacturer Narrative
The customer reported the patient was ordered imaging tests because of the high access gi monitor result.On (b)(6)2023, the customer did indicate that the imaging tests were pet (positron emission tomography) scan (fdg 1 -f) and tomography without contrast that have demonstrated a decrease in lesion.No additional impact to the patient was reported in connection with the event.

• Brand Name: ACCESS GI MONITOR CANCER ANTIGEN 19-9
• Common Device Name: SYSTEM,TEST,CARBOHYDRATE ANTIGEN(CA19-9),FOR MONITOR,MANAGE OF PANCREATIC CANCER
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16348868
• Report Number: 2122870-2023-00062
• Device Sequence Number: 15154416
• Product Code: NIG
• UDI-Device Identifier: 15099590231842
• UDI-Public: (01)15099590231842(17)230228(11)220228(10)125586
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 387687
• Device Catalogue Number: 387687
• Device Lot Number: 125586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown